Immunosuppression represents a pathological status in which the immune system doesn’t work properly due to several reasons, leading to reduced capacity to fight infections and other effects. There is a wide spectrum of conditions of immunosuppression with many underlying pathophysiological mechanisms and different clinical severity. In the BC population, immunosuppressed patients are not rare.
According to current guidelines, intravesical immunotherapy with Bacillus Calmette Guerin (BCG) is recommended for intermediate or high-risk non-muscle-invasive bladder cancer (NMIBC) after trans-urethral resection of bladder tumor (TURBT), as it has been well established its superior to any other conservative treatment in the prevention of BC recurrence and progression. In addition, it is recommended to exercise caution with BCG treatment in immunocompromised and immunosuppressed patients, but a low-risk level of evidence states that BCG treatment maintains its efficacy and safety regardless of immunomodulatory disease conditions.
Our new study, published in Urologic Oncology 2025, represents the largest analysis available exploring the impact of immunomodulation on BCG treatment safety and efficacy,1 aiming to provide further evidence to clinical practice and strengthen NMIBC guidelines assessment.
We identified a large cohort of patients with a BC diagnosis who underwent TURBT followed by BCG immunotherapy between 2007 and 2021 in the Merative Marketscan Research Databases. We utilized multivariable logistic regression modeling that was adjusted for relevant confounders.
We discriminated our cohort into two main groups: immunocompetent and immunocompromised. Among these 20458 BC patients, 6.2% (1277) were affected by an immunocompromised status before TURBT.
Safety was evaluated by assessing the rate of dissemination of BCG infections, whilst efficacy was determined in terms of BC progression and recurrence. The follow-up period was similar in both groups.
As expected, immunocompromised patients had higher median Charlson Comorbidity Index (CCI) scores and a significantly higher rate of each specific comorbidity, resulting in shorter progression-free survival with an increased risk of overall recurrence and a higher chance of progression.
Interestingly, both groups had similar rates of disseminated BCG infection following intravesical treatment.
Based on our findings, BCG has a good safety profile in immunocompromised patients, and we may assume that most of them still benefit from it. On the other hand, in this group of patients, conservative treatment leads to worse survival outcomes in time, so offering upfront radical treatment options could be an option.
Our evaluation could be very significant for clinical practice as optimization of care in recurrent and/or progressive NMIBC remains challenging, especially in frail populations. Also, as a result, given the comparable rates of complications, there are no provided reasons to exclude immunocompromised patients from BCG treatment protocols.
Written by: Roberta Corvino,1 Francesco Del Giudice,1,2 Benjamin I. Chung2
- Department of Maternal, Infant, and Urologic Sciences, “Sapienza” University of Rome, Rome, ITA
- Department of Urology, Stanford University School of Medicine, Stanford, CA, USA
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